RTX-GRT7039 Injections for Knee Osteoarthritis

Recruiting in Palo Alto (17 mi)

+106 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Grünenthal GmbH

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial uses knee injections called RTX-GRT7039 for patients with knee osteoarthritis who still have pain despite usual treatments. The injections aim to reduce knee pain, possibly by affecting pain pathways or inflammation.

Research Team

Eligibility Criteria

This trial is for adults over 18 with knee osteoarthritis who haven't found pain relief from standard treatments. They must be able to consent to the study and have a functional capacity class of I to III, based on specific medical criteria.

Inclusion Criteria

My previous treatments did not relieve my pain.

I am 18 years old or older.

I have been diagnosed with knee osteoarthritis and can still perform daily activities.

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Treatment Details

Interventions

RTX-GRT7039 (Monoclonal Antibodies)

Trial OverviewThe trial is testing RTX-GRT7039 injections for knee pain due to osteoarthritis. It's an open-label, single-arm study where all participants receive the treatment to assess its safety and tolerability.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: RTX-GRT7039Experimental Treatment1 Intervention

Participants will receive injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with highest pain intensity), or each of both knees up to Week 52.